Angeliq

Name: Angeliq

Angeliq Drug Class

Angeliq is part of the drug class:

  • Progestogens and estrogens, fixed combinations

What is the most important information I should know about drospirenone and estradiol?

You should not take this medicine if you have: a bleeding or blood-clotting disorder, circulation problems, unusual vaginal bleeding, kidney disease, liver disease, an adrenal gland disorder, if you have had a hysterectomy, if you have had a heart attack or stroke, or if you have ever had breast or uterine cancer, or a blood clot (especially in your lung or your lower body).

Do not use if you are pregnant.

This medicine should not be used to prevent heart disease, stroke, or dementia. This medicine may actually increase your risk of developing these conditions. Long-term use may also increase your risk of breast cancer or blood clot.

Estradiol may increase your risk of developing a condition that may lead to uterine cancer. Call your doctor at once if you have any unusual vaginal bleeding while using this medicine.

What should I avoid while taking drospirenone and estradiol?

Avoid drinking alcohol while you are taking this medication.

Grapefruit and grapefruit juice may interact with drospirenone and estradiol and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.

What other drugs will affect drospirenone and estradiol?

Other drugs may interact with drospirenone and estradiol, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Angeliq Side Effects

Women rarely have severe side effects from taking estrogens to replace estrogen. Discuss these possible effects with your doctor:

The prolonged use of estrogens has been reported to increase the risk of endometrial cancer (cancer of the lining of the uterus) in women after menopause. This risk seems to increase as the dose and the length of use increase. When estrogens are used in low doses for less than 1 year, there is less risk. The risk is also reduced if a progestin (another female hormone) is added to, or replaces part of, your estrogen dose. If the uterus has been removed by surgery (total hysterectomy), there is no risk of endometrial cancer, and no need to take an estrogen and progestin combination.

It is not yet known whether the use of estrogens increases the risk of breast cancer in women. Although some large studies show an increased risk, most studies and information gathered to date do not support this idea.

Check with your doctor immediately if any of the following side effects occur:

Check with your doctor as soon as possible if any of the following side effects occur:

More common
  • Breast pain or tenderness
  • dizziness or light-headedness
  • headache
  • rapid weight gain
  • swelling of feet and lower legs
  • vaginal bleeding
Rare
  • Breast lumps
  • change in vaginal discharge
  • discharge from nipple
  • nausea and vomiting
  • pains in chest, groin, or leg, especially calf
  • pains in stomach, side, or abdomen
  • pain or feeling of pressure in pelvis
  • severe or sudden headache
  • sudden and unexplained shortness of breath
  • sudden loss of coordination
  • sudden slurred speech
  • sudden vision changes
  • weakness or numbness in arm or leg
  • yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Back pain
  • bloating or gas
  • dizziness
  • general feeling of tiredness
  • flu-like symptoms
  • mental depression
  • muscle aches
  • nausea—taking tablet with food may decrease
  • vaginitis

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

What are some things I need to know or do while I take Angeliq?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists. This medicine may need to be stopped before certain types of surgery as your doctor has told you. If Angeliq is stopped, your doctor will tell you when to start taking this medicine again after your surgery or procedure.
  • This medicine may raise the chance of blood clots, a stroke, or a heart attack. Talk with the doctor.
  • Talk with your doctor if you will need to be still for long periods of time like long trips, bedrest after surgery, or illness. Not moving for long periods may raise your chance of blood clots.
  • If you have high blood sugar (diabetes), talk with your doctor. This medicine may raise blood sugar.
  • Check your blood sugar as you have been told by your doctor.
  • If you are taking a salt substitute that has potassium, potassium-sparing diuretics, or potassium, talk with your doctor.
  • High blood pressure has happened with drugs like this one. Have your blood pressure checked as you have been told by your doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Be sure to have regular breast exams and gynecology check-ups. Your doctor will tell you how often to have these. You will also need to do breast self-exams as your doctor has told you. Talk with your doctor.
  • This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Angeliq.
  • If you drink grapefruit juice or eat grapefruit often, talk with your doctor.
  • Limit your drinking of alcohol.
  • Do not smoke. Smoking raises the chance of heart disease. Talk with your doctor.
  • If you are using this only to treat vaginal dryness, itching, and burning, talk with your doctor to see if a drug used on the skin would be better for you.
  • If you are 65 or older, use this medicine with care. You could have more side effects.
  • This medicine is not approved for use in children. Talk with the doctor.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Angeliq Description

Angeliq tablets, for oral administration, provide a hormone regimen consisting of drospirenone and estradiol.

Drospirenone, (6R,7R,8R,9S,10R,13S,14S,15S,16S,17S)-1,3´,4´,6, 6a,7,8,9,10,11,12,13,14,15,15a,16-hexadecahydro-10,13-dimethylspiro-[17H-dicyclopropa[6,7:15,16]cyclopenta[a]phenanthrene- 17,2´(5H)-furan]-3,5´(2H)-dione (CAS) is a synthetic progestational compound and has a molecular weight of 366.5 and a molecular formula of C24H30O3.

Estradiol USP, (Estra-1,3,5(10)-triene-3,17-diol,17ß), has a molecular weight of 272.39 and the molecular formula is C18H24O2. The structural formulas are as follows:

The inactive ingredients in Angeliq 0.5 mg DRSP/1 mg E2 tablets are: lactose monohydrate NF, corn starch NF, pregelatinized starch NF, povidone 25000 USP, magnesium stearate NF, hydroxylpropylmethyl cellulose USP, macrogol 6000 NF, talc USP, titanium dioxide USP, and red ferric oxide pigment NF.

The inactive ingredients in Angeliq 0.25 mg DRSP/0.5 mg E2 tablets are: lactose monohydrate NF, corn starch NF, pregelatinized starch NF, povidone 25000 USP, magnesium stearate NF, hydroxylpropylmethyl cellulose USP, macrogol 6000 NF, talc USP, titanium dioxide USP, and yellow ferric oxide pigment NF.

Clinical Studies

Effects on Vasomotor Symptoms

Angeliq 0.25 mg DRSP/0.5 mg E2

The efficacy of Angeliq 0.25 mg DRSP/0.5 mg E2 for reducing the frequency and severity of moderate to severe vasomotor symptoms was evaluated in a randomized, double-blind, placebo-controlled trial. A total of 735 postmenopausal women ≥ 40 years of age with a minimum of 7 to 8 moderate to severe hot flashes daily or 50 to 60 moderate to severe hot flashes weekly were randomized to one of the two doses of Angeliq, including DRSP 0.25 mg/0.5 mg E2, estrogen monotherapy, or placebo. The median age of study subjects was 53 years and 68% were Caucasian. Efficacy for vasomotor symptoms was assessed during the 12 weeks of treatment. Compared to placebo, subjects receiving Angeliq 0.25 mg DRSP/0.5 mg E2 achieved statistically significant reduction in the frequency and severity of moderate to severe vasomotor symptoms at Week 4 and at Week 12. The mean difference in daily reduction of frequency of hot flushes between Angeliq 0.25 mg DRSP/0.5 mg E2 and placebo were approximately -2 episodes at Week 4 and -3 episodes at Week 12. Table 4 shows the mean number of hot flushes in the Angeliq 0.25 mg DRSP/0.5 mg E2 and placebo groups and the treatment difference between Angeliq 0.25 mg DRSP/0.5 mg E2 and placebo treatment at Week 4 and at Week 12.

Table 4: Summary Tabulation Of The Number Of Hot Flushes Per Day - Mean Values And Comparisons Between the Active Treatment Group and the Placebo Group, Last Observation Carried Forward
* Mean change from baseline, difference from placebo, 95% confidence interval, and p-value based on an ANCOVA model with treatment and pooled center as factors and baseline measurement as covariate

Treatment

No. of Hot Flushes/Day

Time Period
(week)

Baseline
Mean

Mean Change from Baseline*

Difference from Placebo (95% CI)

p-Values
vs. Placebo*

DRSP/E2 (0.25 mg/0.5 mg) [n=175]

 

 

 

Week 4

10.68

-5.46

-2.02 (-2.89, -1.16)

<0.0001

Week 12

10.68

-7.71

-3.17 (-3.97, -2.37)

<0.0001

Placebo [n=176]

 

 

 

 

Week 4

10.53

-3.44

-

-

Week 12

10.53

-4.54

-

-

Angeliq 0.5 mg DRSP/1 mg E2

Support for treatment of vasomotor symptoms and vaginal and vulvar atrophy was shown through bioequivalence of the E2 component of the Angeliq combination product with a currently marketed 1 mg E2 product. The multiple-dose bioequivalence study evaluated the bioequivalence of E2 from a tablet containing DRSP (2 mg) and E2 (1 mg) relative to E2 1 mg tablet. Angeliq 0.5 mg DRSP/1 mg E2 tablets met the criteria for bioequivalence to the E2 1 mg comparator.

Effects on Endometrium

Angeliq 0.25 mg DRSP/0.5 mg E2

In a one year clinical trial, 661 postmenopausal subjects were treated with Angeliq 0.25 mg DRSP/0.5 mg E2 (N=489) or a comparator drug (N=172). Endometrial biopsies were performed on 407 (83.2%) subjects in the Angeliq group during the treatment period. No endometrial hyperplasias occurred during or after one year of treatment. See Table 5.

Angeliq 0.5 mg DRSP/1 mg E2

In a one year clinical trial of 1,142 postmenopausal subjects treated with 1 mg E2 alone or 1 mg E2 + 0.5, 1, 2, or 3 mg DRSP, endometrial biopsies were performed on 966 (84.6%) subjects during the treatment period. Eight subjects in the E2 monotherapy group developed endometrial hyperplasia (4 simple hyperplasia with no cytological atypia, 3 complex hyperplasia with no cytological atypia, and 1 complex hyperplasia with cytological atypia), and one subject in the 1 mg E2+2 mg DRSP group developed simple hyperplasia with no cytological atypia. Table 5 shows that there were no diagnoses of endometrial hyperplasia in the Angeliq group.

Table 5: Incidence of Endometrial Hyperplasia after up to 12 Months of Treatment
* Includes evaluable and unevaluable endometrial biopsy results

E2 1 mg

Angeliq 0.25 mg DRSP/
0.5 mg E2

Angeliq 0.5 mg DRSP/
1 mg E2

Total No. Subjects Treated

226

489

227

Total No. of
On-Treatment Biopsies*

197 (87.2%)

407 (83.2%)

191 (84.1%)

Hyperplasia

8 (4%)

0 (0%)

0 (0%)

Effects on Uterine Bleeding or Spotting

Angeliq 0.5 mg DRSP/1 mg E2 and Angeliq 0.25 mg DRSP /0.5 mg E2 were evaluated in separate one-year clinical trials investigating the endometrial safety in postmenopausal women with an intact uterus.

Over 12 months in the double-blind trials, the proportions of women with any bleeding or spotting decreased over time. At one year, approximately 22% of women treated with Angeliq 0.5 mg/E2 1.0 mg and 15% of women treated with Angeliq 0.25 mg/E2 0.5 mg had any uterine bleeding or spotting. See Figure 2.

Figure 2: Proportion of Subjects with any Bleeding/Spotting by Month of Angeliq Use

Women's Health Initiative Studies

The WHI enrolled approximately 27,000 predominantly healthy postmenopausal women in two substudies to assess the risks and benefits of daily oral CE (0.625 mg)-alone or in combination with MPA (2.5 mg) compared to placebo in the prevention of certain chronic diseases. The primary endpoint was the incidence of CHD defined as nonfatal MI, silent MI and CHD death], with invasive breast cancer as the primary adverse outcome. A "global index" included the earliest occurrence of CHD, invasive breast cancer, stroke, PE, endometrial cancer (only in the CE plus MPA substudy), colorectal cancer, hip fracture, or death due to other cause. These substudies did not evaluate the effects of CE plus MPA or CE-alone on menopausal symptoms.

WHI Estrogen plus Progestin Substudy

The WHI estrogen plus progestin substudy was stopped early. According to the predefined stopping rule, after an average follow-up of 5.6 years of treatment, the increased risk of breast cancer and cardiovascular events exceeded the specified benefits included in the "global index." The absolute excess risk of events included in the “global index” was 19 per 10,000 women-years.

For those outcomes included in the WHI “global index” that reached statistical significance after 5.6 years of follow-up, the absolute excess risks per 10,000 women-years in the group treated with CE plus MPA were 7 more CHD events, 8 more strokes, 10 more PEs, and 8 more invasive breast cancers, while the absolute risk reductions per 10,000 women-years were 6 fewer colorectal cancers and 5 fewer hip fractures.

Results of the CE plus MPA substudy, which included 16,608 women (average 63 years of age, range 50 to 79; 83.9 percent White, 6.8 percent Black, 5.4 percent Hispanic, 3.9 percent Other) are presented in Table 6. These results reflect centrally adjudicated data after an average follow-up of 5.6 years.

 

Table 6: Relative and Absolute Risk Seen in the Estrogen Plus Progestin Substudy of WHI at an Average of 5.6 Years*†
* Adapted from numerous WHI publications. WHI publications can be viewed at www.nhlbi.nih.gov/whi. † Results are based on centrally adjudicated data. ‡ Nominal confidence intervals unadjusted for multiple looks and multiple comparisons. § Not included in "global index.” ¶ Includes metastatic and non-metastatic breast cancer, with the exception of in situ breast cancer. # All deaths, except from breast or colorectal cancer, definite or probable CHD, PE or cerebrovascular disease. Þ A subset of the events was combined in a "global index", defined as the earliest occurrence of CHD events, invasive breast cancer, stroke, pulmonary embolism, colorectal cancer, hip fracture, or death due to other causes.

Event

Relative Risk
CE/MPA vs. Placebo
(95% nCI‡)

CE/MPA
n=8,506

Placebo
n=8,102

Absolute Risk per 10,000 Women-Years

CHD events

1.23 (0.99–1.53)

41

34

Non-fatal MI

1.28 (1.02–1.632)

31

25

CHD death

1.10 (0.70–1.75)

8

8

All strokes

1.31 (1.03–1.68)

33

25

Ischemic stroke

1.44 (1.09-1.90)

26

18

Deep vein thrombosis§

1.95 (1.43-2.67)

26

13

Pulmonary embolism

2.13 (1.45–3.11)

18

8

Invasive breast cancer¶

1.24 (1.01-1.54)

41

33

Colorectal cancer

0.61 (0.42–0.87)

10

16

Endometrial cancer§

0.81 (0.48–1.36)

6

7

Cervical cancer§

1.44 (0.47-4.42)

2

1

Hip fracture‡

0.67 (0.47–0.96)

11

16

Vertebral fractures§

0.65 (0.46–0.92)

11

17

Lower arm/wrist fractures§

0.71 (0.59-0.85)

44

62

Total fractures§

0.76 (0.69-0.83)

152

199

Overall Mortality#

1.00 (0.83-1.19)

52

52

Global IndexÞ

1.13 (1.02-1.25)

184

165

Timing of the initiation of estrogen therapy relative to the start of menopause may affect the overall risk benefit profile. The WHI estrogen plus progestin substudy stratified by age showed in women 50-59 years of age, a non-significant trend toward reduced risk for overall mortality [HR 0.69 (95 percent CT 0.44-1.07)].

WHI Estrogen-Alone Substudy

The WHI estrogen-alone substudy was stopped early because an increased risk of stroke was observed, and it was deemed that no further information would be obtained regarding the risks and benefits of estrogen alone in predetermined primary endpoints.

Results of the estrogen-alone substudy, which included 10,739 women (average age of 63 years, range 50 to 79; 75.3 percent White, 15.1 percent Black, 6.1 percent Hispanic, 3.6 percent Other), after an average follow-up of 7.1 years are presented in Table 7.

Table 7. Relative and Absolute Risk Seen in the Estrogen-Alone Substudy of WHI*
* Adapted from numerous WHI publications. WHI publications can be viewed at www.nhlbi.nih.gov/whi. † Nominal confidence intervals unadjusted for multiple looks and multiple comparisons. ‡ Results are based on centrally adjudicated data for an average follow-up of 7.1 years. § Not included in “global index.” ¶ Results are based on an average follow-up of 6.8 years. # All deaths, except from breast or colorectal cancer, definite or probable CHD, PE or cerebrovascular disease. Þ A subset of the events was combined in a "global index," defined as the earliest occurrence of CHD events, invasive breast cancer, stroke, pulmonary embolism, colorectal cancer, hip fracture, or death due to other causes.

Event

Relative Risk
CE vs. Placebo

(95% nCI†)

CE
n=5,310

Placebo
n=5,429

Absolute Risk per 10,000 Women-Years

CHD events‡

0.95 (0.78–1.16)

54

57

Non-fatal MI‡

0.91 (0.73–1.14)

40

43

CHD death‡

1.01 (0.71–1.43)

16

16

All stroke‡

1.33 (1.05–1.68)

45

33

Ischemic‡

1.55 (1.19-2.01)

38

25

Deep vein thrombosis‡§

1.47 (1.06-2.06)

23

15

Pulmonary embolism‡

1.37 (0.90–2.07)

14

10

Invasive breast cancer‡

0.80 (0.62-1.04)

28

34

Colorectal cancer‡

1.08 (0.75–1.55)

17

16

Hip fracture‡

0.65 (0.45–0.94)

12

19

Vertebral fractures ‡§

0.64 (0.44–0.93)

11

18

Lower arm/wrist fractures‡§

0.58 (0.47-0.72)

35

59

Total fractures‡§

0.71 (0.64–0.8)

144

197

Death due to other causes¶#

1.08 (0.88-1.32)

53

50

Overall Mortality‡§

1.04 (0.88-1.22)

79

75

Global IndexÞ

1.02 (0.92-1.13)

206

201

For those outcomes included in the WHI "global index" that reached statistical significance, the absolute excess risk per 10,000 women-years in the group treated with CE-alone was 12 more strokes, while the absolute risk reduction per 10,000 women-years was 7 fewer hip fractures.9 The absolute excess risk of events included in the "global index" was a non-significant 5 events per 10,000 women-years. There was no difference between the groups in terms of all-cause mortality.

No overall difference for primary CHD events (nonfatal MI, silent MI and CHD death) and invasive breast cancer incidence in women receiving CE-alone compared with placebo was reported in final centrally adjudicated results from the estrogen-alone substudy, after an average follow-up of 7.1 years.

Centrally adjudicated results for stroke events from the estrogen-alone substudy, after an average follow-up of 7.1 years, reported no significant difference in distribution of stroke subtype or severity, including fatal strokes, in women receiving CE-alone compared to placebo. Estrogen-alone increased the risk for ischemic stroke, and this excess risk was present in all subgroups of women examined.10

Timing of the initiation of estrogen therapy relative to the start of menopause may affect the overall risk benefit profile. The WHI estrogen-alone substudy stratified by age showed in women 50 to 59 years of age, a non-significant trend toward reduced risk for CHD [HR 0.63 (95 percent CI 0.36-1.09)] and overall mortality [HR 0.71 (95 percent CT 0.46-1.11)].

Women's Health Initiative Memory Study

The WHIMS estrogen plus progestin ancillary study of WHI enrolled 4,532 predominantly healthy postmenopausal women 65 years of age and older (47 percent were 65 to 69 years of age, 35 percent were 70 to 74 years of age, and 18 percent were 75 years of age and older) to evaluate the effects of daily CE (0.625 mg) plus MPA (2.5 mg) on the incidence of probable dementia (primary outcome) compared to placebo.

After an average follow-up of 4 years, the relative risk of probable dementia for CE plus MPA versus placebo was 2.05 (95 percent CI 1.21-3.48). The absolute risk of probable dementia for CE plus MPA was 45 versus 22 cases per 10,000 women-years. Probable dementia as defined in this study included Alzheimer’s disease (AD, vascular dementia (VaD) and mixed type (having features of both AD and VaD). The most common classification of probable dementia in the treatment group and the placebo group was AD. Since the ancillary study was conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women [see Warnings and Precautions (5.4), and Use in Specific Populations (8.5)].

The WHIMS estrogen-alone ancillary study of WHI enrolled 2,947 predominantly healthy hysterectomized postmenopausal women 65 to 79 years of age and older (45 percent were age 65 to 69 years of age, 36 percent were 70 to 74 years of age, and 19 percent were 75 years of age and older) to evaluate the effects of daily CE (0.625 mg) on the incidence of probable dementia (primary outcome) compared to placebo.

After an average follow-up of 5.2 years, the relative risk of probable dementia for CE-alone versus placebo was 1.49 (95 percent CI, 0.83 - 2.66). The absolute risk of probable dementia for CE-alone versus placebo was 37 versus 25 cases per 10,000 women-years. Probable dementia as defined in this study included AD, VaD, and mixed type (having features of both AD and VaD). The most common classification of probable dementia in the treatment group and placebo group was AD. Since the ancillary study was conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women [see Warnings and Precautions (5.4) and Use in Specific Populations (8.5)].

When data from the two populations were pooled as planned in the WHIMS protocol, the reported overall RR for probable dementia was 1.76 (95 percent CI 1.19-2.60). Differences between groups became apparent in the first year of treatment. It is unknown whether these findings apply to younger postmenopausal women [see Warnings and Precautions (5.4) and Use in Specific Populations (8.5)].

References

1. Rossouw JE, et al. Postmenopausal Hormone Therapy and Risk of Cardiovascular Disease by Age and Years Since Menopause. JAMA. 2007;297:1465-1477. 2. Hsia J, et al. Conjugated Equine Estrogens and Coronary Heart Disease. Arch Int Med. 2006;166:357-365. 3. Cushman M, et al. Estrogen Plus Progestin and Risk of Venous Thrombosis. JAMA. 2004;292:1573-1580 4. Curb JD, et al. Venous Thrombosis and Conjugated Equine Estrogen in Women Without a Uterus. Arch Int Med. 2006;166:772-780. 5. Chlebowski RT, et al. Influence of Estrogen Plus Progestin on Breast Cancer and Mammography in Healthy Postmenopausal Women. JAMA. 2003;289:3234-3253. 6. Stefanick ML, et al. Effects of Conjugated Equine Estrogens on Breast Cancer and Mammography Screening in Postmenopausal Women With Hysterectomy. JAMA. 2006;295:1647-1657. 7. Anderson GL, et al. Effects of Estrogen Plus Progestin on Gynecologic Cancers and Associated Diagnostic Procedures. JAMA. 2003;290:1739-1748. 8. Shumaker SA, et al. Conjugated Equine Estrogens and Incidence of Probable Dementia and Mild Cognitive Impairment in Postmenopausal Women. JAMA. 2004;291:2947-2958. 9. Jackson RD, et al. Effects of Conjugated Equine Estrogen on Risk of Fractures and BMD in Postmenopausal Women With Hysterectomy: Results From the Women's Health Initiative Randomized Trial. J Bone Miner Res. 2006;21:817-828. 10. Hendrix SL, et al. Effects of Conjugated Equine Estrogen on Stroke in the Women's Health Initiative. Circulation. 2006;113:2425-2434.

What is drospirenone and estradiol (angeliq)?

Drospirenone is a female hormone that helps regulate ovulation and menstruation.

Estradiol is a female hormone involved in development and maintenance of the female reproductive system.

The combination of drospirenone and estradiol is used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. This medication is for use only if you have a uterus (if you have not had a hysterectomy).

Drospirenone and estradiol should not be used to prevent heart disease, strokes, or dementia, because this medicine may actually increase your risk of developing these conditions.

Drospirenone and estradiol may also be used for purposes not listed in this medication guide.

Angeliq dosing information

Usual Adult Dose of Angeliq for Postmenopausal Symptoms:

Treatment of moderate to severe vasomotor symptoms:

drospirenone 0.25 mg/estradiol 0.5 mg tablet or drospirenone 0.5 mg/estradiol 1 mg tablet, 1 tablet orally each day.

Treatment of moderate to severe symptoms of vulvar and vaginal atrophy:

drospirenone 0.5 mg/estradiol 1 mg tablet, 1 tablet orally each day.

What should I avoid while taking Angeliq?

Avoid drinking alcohol while you are taking Angeliq.

Grapefruit and grapefruit juice may interact with drospirenone and estradiol and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.

What other drugs will affect Angeliq?

Other drugs may interact with drospirenone and estradiol, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

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